Global Regulatory Strategic Platform Coordinator (Bogotá)

Responsibilities

• Focal point coordination : Support coordination activities of SRP-COE (Center of Excellence) team.
• Preparation and Delivery : Take charge of preparing and delivering dossiers for Registration, Renewal and Post-approval variation, including labeling, of various products, ensuring strict compliance with local regulations and project specifications.
• Technical Analysis : Conduct thorough technical analysis of all documents, focusing on regulatory classification. Complete dossiers for dispatch in accordance with the legislation of the respective country.
• Risk Assessment : Prepare comprehensive risk assessments for dossiers before submission, evaluating technical feasibility and ensuring all necessary requirements are met.
• Deficiency Letters : Address deficiency letters issued by Health Authorities promptly and effectively, ensuring all necessary corrections and additional documentatio...